A Regulatory Requirement Non Interventional Study to Monitor Safety and Effectiveness of Trajenta Duo in Type 2 Diabetes Patients in Korea

NCT01903356 | Completed Results

• 1 other identifier: 1288.22
• Study Type: observational
• Target: 724
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to monitor the safety profile of Trajenta Duo in Korean patients with type 2 diabetes mellitus (T2DM) in a routine clinical setting.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Incidence Rate of Adverse Events (AE)

  The incidence rate is the number of new cases per population at risk in a given time period. The incidence rate was calculated in patients who take at least one Trajenta Duo

  Up to 26 weeks

Secondary Outcomes (4)

• Change From Baseline in Hemoglobin A1c (HbA1c) After 24 Weeks of Treatment.

  Baseline and Week 24

• Target Effectiveness Response Rate

  24 Weeks

• Relative Effectiveness Response Rate

  24 Weeks

• Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks of Treatment.

  24 Weeks

Study Arms (1)

Patients with T2DM

Drug: Trajenta duo

Interventions

Trajenta duo DRUG

Linagliptin and Metformin

Patients with T2DM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Korean patients with T2DM

You may qualify if:

• No previous exposure to Trajenta, Trajenta Duo
• Should have been started on Trajenta Duo in accordance with the approved label in Korea
• No current participation in clinical trials
• No metformin is inappropriate due to contraindications
• Must sign on the data release consent form

You may not qualify if:

• Individuals with any of the following characteristics will not be able to enter this study:
• Previous exposure to Trajenta, Trajenta Duo
• Current participation in clinical trials
• Patients for whom metformin is inappropriate due to contraindications

Sponsors & Collaborators

• Boehringer Ingelheim: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Unknown Facility

Multiple Locations, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2013
• First Posted: July 19, 2013
• Study Start: July 11, 2013
• Primary Completion: May 30, 2017
• Study Completion: June 10, 2017
• Last Updated: December 21, 2018
• Results First Posted: December 21, 2018

Record last verified: 2018-06

Locations

KR (1)